For Patients

Testim 1% (testosterone gel) is used to treat conditions in men that result from a lack of natural testosterone. It is a naturally occurring male hormone. Common side effects include redness, itching, burning, or hardened skin where the skin patch is worn, breast swelling or tenderness, increased acne or hair growth, headache, depressed mood, or changes in sex drive.

The recommended starting dose of Testim is 5 g of gel (one tube) containing 50 mg of testosterone applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms. Testim may interact with insulin, blood thinners, oxyphenbutazone, or corticosteroids. Tell your doctor all medications you use. Testim should not be used by women. Testosterone can cause birth defects in a fetus. Pregnant women should avoid coming into contact with Testim topical patches or gels, or with a man's skin areas where a patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away. Testim must not be used while breastfeeding.

Our Testim 1% (testosterone gel) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.

Less serious side effects may include:

redness, itching, burning, or hardened skin where the skin patch is worn;

breast swelling or tenderness;

increased acne or hair growth;

headache, depressed mood; or

changes in your sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another drug
and may not reflect the rates observed in practice.

In a controlled clinical study, 304 patients were treated
with Testim® 50 mg or 100 mg or placebo gel for up to 90 days. Two
hundred-five (205) patients received Testim 50 mg or 100 mg daily and 99 patients
received placebo. Subjects could be counted in both Testim treatment groups if
they received both 50 mg and 100 mg at different points in the study and
experienced an adverse reaction at both dose levels. Adverse reactions reported
by ≥ 1% of the Testim patients and greater than placebo are listed in
Table 1.

Table 1: Incidence of Adverse Reactions (Reported by ≥ 1%
of the Testim Patients and Greater than Placebo) in the Controlled Clinical
Trial Through 90 Days

Event

Testim 50 mg
(n=103)

Testim 100 mg
(n=149)

Placebo
(n=99)

Application Site Reactions

2%

4%

3%

Blood Pressure Increased

1%

1%

0%

Gynecomastia

1%

0%

0%

Headache

1%

1%

0%

Hematocrit/hemoglobin Increased

1%

2%

0%

Hot Flushes

1%

0%

0%

Insomnia.

1%

0%

0%

Mood Swings

1%

0%

0%

Smell Disorder

1%

0%

0%

Spontaneous Penile Erection

1%

0%

0%

Taste Disorder

1%

1%

0%

The following adverse reactions
occurred in fewer than 1% of patients but were greater in Testim groups
compared to the placebo group: activated partial thromboplastin time prolonged,
blood creatinine increased, prothrombin time prolonged, appetite increased,
sensitive nipples, and acne.

In this clinical trial of
Testim, six patients had adverse reactions that led to their discontinuation.
These events included: depression with suicidal ideation, urinary tract
infection, mood swings and hypertension. No Testim patients discontinued due to
skin reaction. In one foreign Phase 3 trial, one subject discontinued due to a
skin-related adverse reaction.

In the pivotal U.S. and
European Phase 3 trials combined, at the 50 mg dosage strength, the percentage
of subjects reporting clinically notable increases in hematocrit or hemoglobin
were similar to placebo. However, in the 100 mg dose group, 2.3% and 2.8% of
patients had a clinically notable increase in hemoglobin ( ≥ 19 g/dL) or
hematocrit ( ≥ 58%), respectively, compared to 1.0% and 1.5% of patients
in the placebo group, respectively.

In the combined US and European open label extension
studies, approximately 140 patients received Testim for at least 6 months. The
results from these studies are consistent with those reported for the US
controlled clinical trial.

Postmarketing Experience

The following adverse reactions have been identified
during post-approval use of testosterone gel products. Because the reactions
are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.

Secondary Exposure to Testosterone in Children

Cases of secondary exposure to testosterone resulting in
virilization of children have been reported in postmarketing surveillance of
testosterone gel products. Signs and symptoms of these reported cases have
included enlargement of the clitoris (with surgical intervention) or of the
penis, development of pubic hair, increased erections and libido, aggressive
behavior, and advanced bone age. In most cases with a reported outcome, these
signs and symptoms were reported to have regressed with removal of the
testosterone gel exposure. In a few cases, however, enlarged genitalia did not
fully return to age-appropriate normal size, and bone age remained modestly
greater than chronological age. In some of the cases, direct contact with the
sites of application on the skin of men using testosterone gel was reported. In
at least one reported case, the reporter considered the possibility of
secondary exposure from items such as the testosterone gel user's shirts and/or
other fabric, such as towels and sheets [see WARNINGS
AND PRECAUTIONS].